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Drugs Recalls

Prescription and over-the-counter medications

17,302 Total Recalls

Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30.

Dr. Reddy's Laboratories

Class I - Dangerous

CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Oct 9, 2024 Prescription Drugs Nationwide View Details →

Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.

ACCORD HEALTHCARE

Class I - Dangerous

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

Oct 10, 2024 Prescription Drugs Nationwide View Details →

Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30.

Dr. Reddy's Laboratories

Class I - Dangerous

CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Oct 9, 2024 Prescription Drugs Nationwide View Details →

NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-027-58

Fresenius Kabi Compounding

Class I - Dangerous

cGMP violations

Sep 25, 2024 Prescription Drugs Nationwide View Details →

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-010-58

Fresenius Kabi Compounding

Class I - Dangerous

cGMP violations

Sep 25, 2024 Prescription Drugs Nationwide View Details →

EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58

Fresenius Kabi Compounding

Class I - Dangerous

cGMP violations

Sep 25, 2024 Prescription Drugs Nationwide View Details →

Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-028-59

Fresenius Kabi Compounding

Class I - Dangerous

cGMP violations

Sep 25, 2024 Prescription Drugs Nationwide View Details →

AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg,

C & A Naturistics

Class I - Dangerous

Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.

Oct 8, 2024 Prescription Drugs Nationwide View Details →

NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-025-58

Fresenius Kabi Compounding

Class I - Dangerous

cGMP violations

Sep 25, 2024 Prescription Drugs Nationwide View Details →

OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473 mL) bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., Fairfield, NJ 07004, NDC 71399-0039-06.

Akron Pharma

Class I - Dangerous

CGMP Deviations

Oct 15, 2024 Other Drugs Nationwide View Details →

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-024-58

Fresenius Kabi Compounding

Class I - Dangerous

cGMP violations

Sep 25, 2024 Prescription Drugs Nationwide View Details →

Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-079-56

Fresenius Kabi Compounding

Class I - Dangerous

cGMP violations

Sep 25, 2024 Prescription Drugs Nationwide View Details →

Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-014-58

Fresenius Kabi Compounding

Class I - Dangerous

cGMP violations

Sep 25, 2024 Prescription Drugs Nationwide View Details →

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58

Fresenius Kabi Compounding

Class I - Dangerous

CGMP violations

Sep 25, 2024 Prescription Drugs Nationwide View Details →

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-029-58

Fresenius Kabi Compounding

Class I - Dangerous

cGMP violations

Sep 25, 2024 Prescription Drugs Nationwide View Details →

First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil, petrolatum. NET Wt. 1 OZ (28.4 g) per tube, Distributed by: Rugby Laboratories, Indianapolis, IN 46268. Made in China. NDC: 0536-1271-80

Zhejiang Jingwei Pharmaceutical Co.

Class I - Dangerous

Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.

Sep 11, 2024 Other Drugs Nationwide View Details →

Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.

Bionpharma

Class I - Dangerous

Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.

Sep 17, 2024 Prescription Drugs Nationwide View Details →

Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Accord Healthcare Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad 382 213, India. Mfg. Lic. No.: G/28/1336, NDC 16729-288-38

ACCORD HEALTHCARE

Class I - Dangerous

Failed Impurities/Degradation Specifications.

Oct 1, 2024 Prescription Drugs Nationwide View Details →

Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02.

VIONA PHARMACEUTICALS

Class I - Dangerous

Crystallization

Sep 24, 2024 Prescription Drugs View Details →

Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.

Breckenridge Pharmaceutical

Class I - Dangerous

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Oct 10, 2024 Prescription Drugs Nationwide View Details →